Side Effects of Vascular Endothelial Growth Factor (VEGF) and Epidermal Growth Factor Receptor (EGFR) Directed Therapy (Mabtornib)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
J.A. Gietema, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00657098
First received: April 8, 2008
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

Angiogenesis inhibitors and EGFR inhibitors not only have anti tumor activity but also modify physiological processes. This study evaluates effects on vascular function, endocrine function and metabolism. Changes in these parameters will be analysed for predictive value for treatment efficacy.


Condition
Metastatic Malignancies

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mabtornib Protocol.Vascular, Metabolic and Hormonal Effects of Angiogenesis Inhibitors and Epidermal Growth Factor Receptor Inhibitors

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • Characteristics, frequency and severity of vascular, metabolic and hormonal side effects of angiogenesis and EGFR inhibitors. [ Time Frame: after 3 and after 6 weeks of treatment ] [ Designated as safety issue: No ]
    Vascular function tests at baseline, after 3 and after 6 weeks of treatment, blood and urine measurements as long as treatment is continued.


Secondary Outcome Measures:
  • DNA analysis [ Time Frame: day -7 till day -1 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum Plasma Urine DNA


Estimated Enrollment: 240
Study Start Date: March 2008
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who will be treated with angiogenesis inhibitors or EGFR inhibitors

Criteria

Inclusion Criteria:

  • Patients who will start with an angiogenesis inhibitor or EGFR inhibitor
  • Concomittant chemotherapy, immunotherapy or radiotherapy is allowed
  • Age above 18 years at start of treatment
  • Willingness to give written informed consent

Exclusion Criteria:

  • Unable to give written informed consent
  • Age under 18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657098

Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Principal Investigator: Jourik A Gietema, MD/PhD University Medical Center Groningen, The Netherlands
  More Information

No publications provided

Responsible Party: J.A. Gietema, Principal Investigator, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT00657098     History of Changes
Other Study ID Numbers: 2007/203
Study First Received: April 8, 2008
Last Updated: May 26, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
Side effects
Angiogenesis inhibitors
Epidermal growth factor receptor inhibitors
Tyrosinekinase inhibitors

Additional relevant MeSH terms:
Neoplasms
Mitogens
Angiogenesis Inhibitors
Endothelial Growth Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014